None listed
Conditions
Brief summary
The gut microbiome plays a pivotal role in modulating gastrointestinal function, emotional well-being, sleep quality, and immune responses through complex bidirectional communication within the microbiota-gut-brain axis. Disruptions in gut microbial composition have been associated with digestive discomfort, altered bowel habits, psychological distress, and sleep disturbances. Emerging clinical evidence supports the potential for targeted probiotic interventions to improve these symptoms by restoring microbial balance and modulating neuroimmune pathways. This randomised, double-blind, placebo-controlled trial will investigate the effect of low and high-dose Lactiplantibacillus plantarum BMB18 (DSM 35214) supplementation in improving digestive function over six weeks compared to placebo, with a follow-up at eight weeks. This trial will also investigate the effects of the dietary probiotic supplement on self-reported indicators of quality of life, sleep quality, and mood, such as depression, anxiety, and stress. The present study will recruit healthy male and female adults aged between 18 and 65 years who report mild digestive symptoms and/or occasional sleep or mood disturbances without a diagnosis of any major gastrointestinal or psychiatric disorders (e.g. IBS or MDD). The outcomes of this trial will broaden the literature on the promising potential of probiotic supplementation by characterising clinical benefits and generating translational evidence for future trials as the first study examining the effects of L. plantarum BMB18 in humans.
Interventions
The parallel, dual-centre, randomized, double-blind, placebo-controlled, three-arm intervention trial will examine the effect of low and high doses of Lactiplantibacillus plantarum BMB18 (DSM35214) on digestive function, mood, sleep and quality of life.
Participants will be randomized into one of three study arms: Placebo, low-dose BMB18 group (1 billion CFU/day) or high-dose BMB18 group (10 billion CFU/day). Participants will take one oral capsule daily for 6 weeks and complete a 2-week follow
The parallel, dual-centre, randomized, double-blind, placebo-controlled, three-arm intervention trial will examine the effect of low and high doses of Lactiplantibacillus plantarum BMB18 (DSM35214) on digestive function, mood, sleep and quality of life. Participants will be randomized into one of three study arms: Placebo, low-dose BMB18 group (1 billion CFU/day) or high-dose BMB18 group (10 billion CFU/day). Participants will take one oral capsule daily for 6 weeks and complete a 2-week follow-up. Capsule return counts and blister-pack checks will quantify adherence. Participants will be asked to complete all self-reported questionnaires individually and online via REDCap including one brief questionnaire weekly about their digestive symptoms, one brief questionnaire at week 1 to report any adverse events, and a set of questionnaires at three timepoints (week 0, week 6 and week 8) regarding their digestive symptoms, mood, sleep quality, quality of life, dietary intake and physical activity. Participants will be asked to attend two study visits (week 0 and week 6) at the Food, Nutrition and Dietetics Laboratory at La Trobe University, Bundoora Campus. Early-morning venous blood samples will be drawn by a trained phlebotomist, and anthropometric data will be obtained.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Report mild digestive symptoms (e.g. bloating, discomfort) and/or occasional sleep or mood disturbances • Fluent in English • Willing to abstain from starting new probiotic, prebiotic, antibiotic, or psychotropic treatments during the intervention (unless medically necessary)
Exclusion criteria
• Diagnosed gastrointestinal disorders (e.g. IBD) • Diagnosed psychiatric disorders (e.g. MDD) • Current use of probiotic supplements • Use of systemic antibiotics or antifungals within the past 6 weeks • Current pregnancy or breastfeeding • Gastrointestinal surgeries, including colectomy • Autoimmune, inflammatory, or metabolic disorders • Known hypersensitivity to capsule excipients
Outcome results
None listed